Summary for ARTG Entry:
Vela Diagnostics Australia Pty Ltd - BK virus IVDs
ARTG entry for
Medical Device Included - IVD Class 3
Vela Diagnostics Australia Pty Ltd
Level 9 Avaya House 123 Epping Road,NORTH RYDE, NSW, 2113
ARTG Start Date
Medical Device Class 3
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Vela Operations Singapore Pte Ltd
2-4/5/6 The Kendall 50 Science Park Road
Science Park II, , 117406
1. BK virus IVDs
CT758 BK virus IVDs
The Sentosa SA BKV Quantitative PCR Test is a real-time PCR-based in vitro diagnostic test intended for
use in the detection and quantitation of BK virus (BKV) DNA using Sentosa SX101 instrument in
conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument. For human EDTA plasma, serum and
urine samples, Sentosa SX Virus Total Nucleic Acid Kit v2.0 is used for DNA extraction; and for human
EDTA whole blood samples, Sentosa® SX Whole Blood Kit is used for DNA extraction.
No Specific Conditions included on Record
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